Class I · High risk
Robert Wood Johnson University
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class I · High risk
Hackensack University Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Truman Medical Center Lakewood
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Truman Medical Center Lakewood
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
St Lukes East Lees Summit
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Providence Hospital Southfield
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Walter Reed Natl Mil Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Walter Reed Natl Mil Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Sinai Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Holy Cross Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Olathe Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Methodist Hospital Northlake
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Advocate Good Samaritan Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Advocate Good Samaritan Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Bridgeport Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
The Medical Center of Aurora
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
University of Alabama Birmingham TPN Neonatal Starter Bag
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility; improperly crimped fliptop vials
Class II · Moderate risk
Clinimix E 4.25/10 sulfite-free
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Class II · Moderate risk
Sodium Tetradecyl SO4 0.3% Inj.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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